Strophanthin^®-G (Solution) Instructions for Use

Marketing Authorization Holder

Experimental Plant SRLS, LLC (Ukraine)

Manufactured By

Experimental Plant SRLS, LLC (Ukraine)

Or

Pharmaceutical Company Zdorovye, LLC (Ukraine)

ATC Code

C01AC01 (Strophanthin^®-G)

Active Substance

Ouabain (Ph.Eur. European Pharmacopoeia)

Dosage Form

Strophanthin®-G

Solution for intravenous injection 0.25 mg/ml: amp. 1 ml 10 pcs.

Dosage Form, Packaging, and Composition

Solution for intravenous injection colorless, transparent.

Excipients: citric acid monohydrate, sodium hydroxide, water for injections.

1 ml – ampoules (10) – carton packs.

Clinical-Pharmacological Group

Cardiac glycoside

Pharmacotherapeutic Group

Cardiotonic agent – cardiac glycoside

Pharmacological Action

Cardiostimulatory, antiarrhythmic agent, blocks Na+/K+-ATPase of the cardiomyocyte cell membrane. Increases the strength and rate of heart contractions ( positive inotropic effect), reduces AV conduction ( negative dromotropic effect), stimulates (in subtoxic and toxic doses) the formation of heterotopic impulses due to a decrease in the excitation threshold and lowers heart rate ( negative chronotropic effect).

In heart failure, it increases stroke volume and minute volume of blood, improves ventricular emptying, reduces heart size and lowers myocardial oxygen demand. The effect appears 2-10 minutes after intravenous injection, reaches a maximum after 30-120 minutes and lasts 1-3 days.

Pharmacokinetics

Plasma protein binding – 40%, not metabolized, excreted by the kidneys unchanged.

Indications

Acute heart failure or decompensated chronic heart failure, supraventricular tachycardia, atrial flutter and fibrillation.

ICD codes

Dosage Regimen

Intravenous, slowly. The dose is selected individually depending on the nosology and the patient’s response to therapy.

With an average rate of digitalization during the saturation period, 250 mcg is administered 2 times/day with a 12-hour interval. The duration of the saturation period averages 2 days. If necessary, an additional dose of 100-150 mcg can be administered at an interval of 0.5 to 2 hours. The daily dose should not exceed 1 mg, which corresponds to 4 ml of injection solution. The maintenance dose, as a rule, does not exceed 250 mcg/day.

Adverse Reactions

From the digestive system decreased appetite, nausea, vomiting, diarrhea.

From the cardiovascular system arrhythmias, AV block.

From the central nervous system headache, dizziness, drowsiness, confusion, sleep disorders, delirious psychosis, visual disturbances.

Other allergic reactions, thrombocytopenia, thrombocytopenic purpura, nosebleeds, petechiae, gynecomastia.

Contraindications

Glycoside intoxication, hypersensitivity to the active substance.

Use in Renal Impairment

Use with caution in chronic renal failure. In case of impaired renal excretory function, the dose should be reduced (prevention of glycoside intoxication).

Geriatric Use

Use with caution in elderly patients. The likelihood of overdose is increased in elderly patients.

Special Precautions

Use with caution in bradycardia, acute myocardial infarction, ventricular tachycardia, AV block II-III degree, isolated mitral stenosis, hypertrophic obstructive cardiomyopathy, sick sinus syndrome, thoracic aortic aneurysm, WPW syndrome, cardiomegaly (dilated type of myocardial damage), chronic renal failure, severe electrolyte imbalances (hypokalemia, hypomagnesemia, hypercalcemia, hypernatremia), hypertension in the pulmonary circulation, in elderly patients.

Given the narrow therapeutic range, careful medical supervision and individual dose selection are necessary during treatment. In case of impaired renal excretory function, the dose should be reduced (prevention of glycoside intoxication). The likelihood of overdose is increased with hypokalemia, hypomagnesemia, hypercalcemia, hypernatremia, severe dilatation of the heart chambers, cor pulmonale, alkalosis, and in elderly patients. Particular caution and ECG monitoring are required in case of impaired AV conduction.

The earliest signs of glycoside intoxication are decreased appetite, vomiting, cardiac rhythm disturbances (ventricular paroxysmal tachycardia, ventricular extrasystole, including bigeminy, multifocal ventricular extrasystole, nodal tachycardia, sinoatrial block, atrial fibrillation and flutter, AV block); diarrhea, abdominal pain, necrosis of the intestinal walls; coloring of visible objects in yellow-green, flickering of “flies” before the eyes, decreased visual acuity, perception of objects in reduced or enlarged form; neuritis, radiculitis, manic-depressive syndrome, paresthesia.

Treatment of glycoside intoxication: discontinuation of cardiac glycosides or reduction of subsequent doses and increase in the time intervals between doses, administration of antidotes (unithiol, EDTA), symptomatic therapy. As antiarrhythmics of class I (lidocaine, phenytoin). For hypokalemia – intravenous administration of potassium chloride (6-8 g/day based on 1-1.5 g per 0.5 l of 5% dextrose solution and 6-8 units of insulin; administered by drip over 3 hours). For severe bradycardia, AV block – m-cholinolytics. It is dangerous to administer beta-adrenergic stimulants due to the possible enhancement of the arrhythmogenic effect of cardiac glycosides. For complete transverse block with Morgagni-Adams-Stokes attacks – temporary electrocardiostimulation.

Drug Interactions

Adrenergic stimulants, methylxanthines, reserpine, tricyclic antidepressants increase the likelihood of developing cardiac rhythm disturbances.

Beta-blockers and class IA antiarrhythmics, verapamil and magnesium sulfate enhance the severity of AV conduction reduction.

Quinidine, methyldopa, clonidine, spironolactone, amiodarone, verapamil, captopril, erythromycin and tetracycline increase blood concentration (competitive reduction of secretion by the proximal renal tubules).

Corticosteroids and diuretics increase the risk of hypokalemia and hypomagnesemia, ACE inhibitors and angiotensin receptor blockers – reduce it. Calcium salts, catecholamines, diuretics (to a greater extent thiazides and carbonic anhydrase inhibitors), corticosteroids, insulin increase the risk of glycoside intoxication.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.